UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003097 |
|---|---|
| Receipt number | R000003757 |
| Scientific Title | Construction of a database for normal cerebral blood flow images using 123I-IMP SPECT |
| Date of disclosure of the study information | 2010/02/01 |
| Last modified on | 2014/07/28 11:30:15 |
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Basic information
Public title
Construction of a database for normal cerebral blood flow images using 123I-IMP SPECT
Acronym
Construction of a database for normal cerebral blood flow images
Scientific Title
Construction of a database for normal cerebral blood flow images using 123I-IMP SPECT
Scientific Title:Acronym
Construction of a database for normal cerebral blood flow images
Region
| Japan |
Condition
Condition
cerebrovascular disorder, neurodegenerative disease, epilepsy, etc.
Classification by specialty
| Neurology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct a database for cerebral blood flow images in normal subjects using a new SPECT machine introduced in Kyoto University Hospital and to evaluate their distribution patterns.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Regional cerebral blood flow images by 123I-IMP SPECT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
30 minutes SPECT acquisition 5 minutes after injection of 123I-IMP (167MBq)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy subjects
2. Subjects who agree the purpose and procedure of the study with the paper agree
Key exclusion criteria
1. Subjects with a past history of central nervous system disorders
2. Subjects with MMSE (Mini-mental state examination) less or equal 24
3. Subjects who have difficulty in acquiring SPECT
4. Subjects who have difficulty in acquiring MRI revealed by a MRI questionnaire
5. Subjects with neurological signs (hemiparesis, extrapyramidal sign, bulbar palsy, motor ataxia, oculomotor disorder, aphasia, apraxia, agnosia, hemispatial neglect, convulsion, etc.)
6. Subjects with critical illness (malignant tumor, heart failure, liver failure, renal failure, endocrine disease, etc.)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenao Fukuyama |
Organization
Kyoto University Graduate School of Medicine
Division name
Human Brain Research Center
Zip code
Address
Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Graduate School of Medicine
Division name
Human Brain Research Center
Zip code
Address
TEL
075-751-3695
Homepage URL
Sponsor or person
Institute
Human Brain Research Center
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
National Treasury
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2010 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 26 | Day |
Last modified on
| 2014 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003757
